MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS EYHANCE; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIW300

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: unknown, as information was requested but not provided.Section d6a - implant date: does not apply - lens was not implanted.Section d6b - explant date: does not apply - lens was not implanted and therefore not explanted.Section e1 - first/given name: unknown, as information was requested but not provided.Section e1 - last name: unknown, as information was requested but not provided.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the injector of the preloaded intraocular lens (iol) failed and the plunger broke through the toric lens.The procedure was completed using a dcb00v model lens instead of diw because no further diw model lenses were available.There were no reported patient injuries and no additional information was received.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: (b)(6) 2023 section h3 - device evaluated by manufacturer? yes device evaluation: the product was returned to the manufacturing site for evaluation.Product evaluation was performed under magnification.The complaint device was received with the plunger rod fully retracted.The device assembly was inspected and presented with no issues.The complaint cartridge presented with the lens stuck in the cartridge.The cartridge and cartridge tip could be observed to be bulging around the lens.The trailing haptic was observed to be unfolded.The lens could not be retrieved for evaluation.In addition, videos provided by the customer were evaluated.One video displayed a device where the lens was overridden and became stuck in the cartridge tip.The other video displayed a device where the plunger rod overrode the lens and punctured the side of the cartridge deforming the cartridge tip.The complaint issue of lens damaged could not be confirmed during product evaluation.The complaint issue of override was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other issues observed during product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Corrected data: upon further review it was noted that "g4" field for the pma number was inadvertently populated with p980040 on the initial mdr; the field should have been left blank.Therefore, the information is being corrected in this supplemental mdr report as per the following: section g4: pma/510(k) number: this report is being filed on an international device; tecnis toric ii optiblue 1-piece iol, model diw that has a similar device, tecnis toric 1-piece iol model diu series which is distributed in the unites states under pma p980040.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS EYHANCE
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17761820
• MDR Text Key: 323583324
• Report Number: 3012236936-2023-02331
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474741331
• UDI-Public: (01)05050474741331(17)240916
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIW300
• Device Catalogue Number: DIW300I250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1